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U.S. Department of Health and Human Services

Medical Device Recalls
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  Medical Device Recalls see related information
Date Initiated by Firm July 11, 2011
Create Date May 14, 2012
Recall Status1 Terminated 3
Recall Number Z-1542-2012
Recall Event ID 61475
Product Norco Shoulder Pulley

Distributed by North Coast Medical, Gilroy, CA.

Used to improve range of shoulder movement and coordination following a stroke, shoulder injury or surgery.
Code Information Product number NC52069. Product does not have lot/serial numbers, expiration dates or UPC numbers.
Recalling Firm/
Manufacturer		 North Coast Medical Inc
8100 Camino Arroyo
Gilroy CA 95020-7304
For Additional Information Contact Cheri Koehler
800-821-9319 Ext. 121
Manufacturer Reason
for Recall		 Potential for plastic D-ring to break during use and cause injury.
Action North Coast Medical began contacting customers of the recall on July 13, 2011 by telephone. A phone script was used to inform customers of the affected product, problem, and actions to be taken by the customers. Information was provided for customers to return affected product. Affected devices were re-worked and inspected. Contact the firm by e-mail at www.ncmedical.com for questions regarding this recall.
Quantity in Commerce 2364 units
Distribution Worldwide Distribution-USA (nationwide) and the countries of Australia, Canada, Switzerland, Germany, Great Britain and the Netherlands.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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